(47 days)
The Sonic Window is intended for the visualization of vasular access guidance of needles and catheters (Insertion of Peripheral Intravenous (PIV) Catheters as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only.
The Sonic Window is a fully integrated handheld ultrasound imaging system that combines electronics, transducer, display and battery into the same device. The device is designed and optimized to visualize real-time ultrasound images on a Coronal (Constant Imaging Depth) plane positioned at a distance (depth) from the transducer that is controllable by the user.
The Sonic Window device is an integrated handheld ultrasound imaging system designed for the visualization of peripheral vessels and assessment of vessel width and depth for needle/catheter placement. It is intended for use by medical professionals via prescription.
There is no study described that proves the device meets specific acceptance criteria based on metrics like sensitivity, specificity, or accuracy for its intended clinical use. The document primarily focuses on non-clinical testing for safety and technical equivalence to predicate devices.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Acoustic Output | Ispta.3 ≤ 720 mW/cm² | 3.4 mW/cm² |
| MI ≤ 1.9 | 0.29 | |
| TI Type: TIS | TIS | |
| TI Value: Not specified, but within limits (implied by MI/Ispta.3) | 0.16 | |
| IPA.3 at MImax: Not specified, but within limits | 7.3 W/cm² | |
| Electrical Safety | Compliance with IEC 60601-1 (including Amendments 1 & 2) | Stated compliance |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2: 2001 (Group 1 Class B) | Stated compliance |
| Programmable Electrical Medical Systems (PEMS) | Compliance with IEC 60601-1-4 | Stated compliance |
| Mechanical Integrity | Withstand mechanical shock and vibration (IEC 60068 series) | Stated compliance |
| Shipping Durability | Packaging withstands shipping (ISTA Project 2A) | Stated compliance |
| Altitude Performance | Operation unaffected at higher altitudes | Stated compliance |
| Material Robustness & Cleaning Resistance | Enclosure material robustness and resistance to cleaning materials | Stated compliance |
Study Details:
- Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical engineering and safety tests, not a clinical test set with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance was not established as part of the described non-clinical testing.
- Adjudication method for the test set: Not applicable. No clinical test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an ultrasound system, not an AI-assisted diagnostic tool as described in this document.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device.
- The type of ground truth used: For the non-clinical tests, the "ground truth" was based on established engineering and safety standards (e.g., maximum permissible acoustic output, compliance with IEC standards for electrical safety and EMC, mechanical and environmental endurance specifications).
- The sample size for the training set: Not applicable. This document does not describe machine learning or AI components requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.